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A study to compare between two drugs ALPRAZOLAM and DIAZEPAM to induce forgetfulness(amnesia) in the operating room during anesthesia to make lower part of the body numb(spinal anesthesia).

Comparative evaluation of Anterograde amnesia provided by oral premedication with alprazolam and diazepam for spinal anaesthesia-A Randomized trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018558
Enrollment
80
Registered
2019-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K400- Bilateral inguinal hernia, with obstruction, without gangrene Health Condition 2: N210- Calculus in bladder Health Condition 3: N201- Calculus of ureter Health Condition 4: N809- Endometriosis, unspecified Health Condition 5: N433- Hydrocele, unspecified Health Condition 6: C402- Malignant neoplasm of long bones of lower limb Health Condition 7: M847- Nontraumatic fracture, not elsewhere classified Health Condition 8: M179- Osteoarthritis of knee, unspecified Health Con

Interventions

Intervention1: Tablet ALPRAZOLAM: 0.5mg, single time administration 2 hours prior to scheduled surgery. Control Intervention1: Tablet DIAZEPAM: 10mg, single dose administration 2 hours prior to surger

Sponsors

PIRIYADARSHINIMU
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Weight >50kg. 2.Surgery lasting atleast for an hour. 3.Patients posted for elective surgery under spinal anaesthesia without additives for spinal anaesthesia. 4.ASA grade 1 & 2.

Exclusion criteria

Exclusion criteria: 1.Pregnant and lactating females. 2.Patients hypersensitive or having any contraindications to study drugs. 3.Patients with any psychiatric illness. 4.Patients on cns depressants or any other psychiatric medications. 5.Morbidly obese patients 6.Patients with history suggestive of obstructive sleep apnea

Design outcomes

Primary

MeasureTime frame
Anterograde amnesiaTimepoint: 30 minutes after the surgery in the postoperative period

Secondary

MeasureTime frame
Sedation and AnxietyTimepoint: 30 minutes prior and after the surgery

Countries

India

Contacts

Public ContactPIRIYADARSHINI MU

Kasturba Medical College, Manipal Academy of Higher Education, Manipal.

Hmkrishna20032002@gmail.com9448983314

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026